Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. The main questions it aims to answer are:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI guided TIPS | Experimental | TIPS procedure will be conducted under the guidance of AI model |
|
| Artificially blinded TIPS | Placebo Comparator | TIPS will be conducted based on the experience of operators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI guided TIPS | Other | The TIPS procedure will be conducted under the guidance of AI model which was constructed based on the pre-operation enhanced CT images and intra-operation DSA images. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of punctures | The number of punctures is defined as the number of punctures to the liver during the establishment of the puncture channel during the TIPS procedure. | From the beginning to the end of the TIPS procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dose | Radiation dose from the TIPS procedure. | From the beginning to the end of the TIPS procedure. |
| Surgical success rate | Procedural success was defined as the success of placing a stent and reducing the portal pressure gradient during the TIPS procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Portal pressure gradient | The hepatic venous pressure gradient (HVPG) is an indirect method of assessing the portal pressure gradient by determining the difference between wedged hepatic venous pressure (WHVP) and free hepatic venous pressure (FHVP). pressure (FHVP), which reflects the pressure difference between the portal vein and the intra-abdominal vena cava. | From the beginning to the end of the TIPS procedure. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Chen | Contact | +8615971480677 | chan0812@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Artificially blinded TIPS | Other | The TIPS procedure will be conducted based on the experience of operators. |
|
| From the beginning to the end of the TIPS procedure. |
| Complications | Complications are defined as bleeding, infection, and other complications due to puncture. | From enrollment to the end of the TIPS procedure at 3 months. |
| Wuhan Union Jinyinhu Hospital | Wuhan | Hubei | 430022 | China |
|
| Wuhan Union West Hospital | Wuhan | Hubei | 430022 | China |